Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults

Summary

Gates MRI-RSM01-101 was a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and tolerability, pharmacokinetics, occurrence of Anti-drug antibody (ADA), and assessment of neutralizing antibody against RSV after administration of single intravenous or intramuscular doses of RSM01 to healthy adults.

Timeline

Start

2021-11-16

Primary completion

2022-08-23

Completion

2022-12-07

Publications

• White JT, Terstappen J, Levi M, Radivojevic A, Noble R, Anderson AB, Wise-Blackman G, Dunne MW. Replacing serum with dried blood microsampling for pharmacokinetics, viral neutralisation and immunogenicity bioanalysis supporting future paediatric development of RSM01, a candidate respiratory syncytial virus neutralising monoclonal antibody. BMC Infect Dis. 2024 Dec 18;24(1):1403. doi: 10.1186/s12879-024-10196-4.
• Bonavia A, Levi M, Rouha H, Badarau A, Terstappen J, Watson S, Anderson AB, White JT, Ananworanich J, Taylor D, Radivojevic A, Shaffer M, Stamm LM, Dunne MW. RSM01, a novel respiratory syncytial virus monoclonal antibody: preclinical characterization and results of a first-in-human, randomised clinical trial. BMC Infect Dis. 2024 Dec 3;24(1):1378. doi: 10.1186/s12879-024-10120-w.
• Terstappen J, Delemarre EM, Versnel A, White JT, Derrien-Colemyn A, Ruckwardt TJ, Bont LJ, Mazur NI. RSV Neutralizing Antibodies in Dried Blood. J Infect Dis. 2024 Jul 25;230(1):e93-e101. doi: 10.1093/infdis/jiad543.

Drugs

Indications